Clinical Trials Subject Matter Expert (SME)

Position SummaryPrometheus Federal Services (PFS) is a trusted partner to federal health agencies. We are exploring the addition of an experienced Clinical Trials Subject Matter Expert (SME) to provide leadership in planning, coordinating, and executing decentralized clinical trials (DCTs) in support of the Veterans Health Administration (VHA). The Clinical Trials SME will serve as a trusted advisor to government and industry stakeholders, overseeing complex clinical research activities, ensuring regulatory and ethical compliance, and advancing scalable decentralized research models. This role combines strategic oversight with hands-on study coordination, supporting protocol development, regulatory submissions, sponsor engagement, and day-to-day execution of clinical studies. The ideal candidate brings deep experience within VA research environments, strong regulatory acumen, and the ability to collaborate across multidisciplinary teams to deliver high-quality, compliant clinical research initiatives.Essential Duties and ResponsibilitiesLead and execute Decentralized Clinical Trial (DCT) data auditing, oversight, and end-to-end study coordination to ensure data integrity and protocol adherenceDirect and facilitate cross-functional meetings with internal teams, and external stakeholders, including FDA representatives, industry sponsors, and VA research groups, to advance DCT initiativesAuthor, review, and contribute to high-impact DCT documentation and deliverables, including VA Institutional Review Board (IRB) and Office of Research and Development (ORD) Standard Operating Procedures, training webinars, Centralized Clinical Research System (CCRS) reports, executive-level slide decks, and stakeholder engagement sessionsEngage with sponsors to identify, evaluate, and onboard new DCT opportunities, translating research concepts into executable study designsDevelop and negotiate study protocols and research agreements, including budgets, Confidential Disclosure Agreements (CDAs), Statements of Work (SOWs), Cooperative Research and Development Agreements (CRADAs), and Tele-Health Service Agreements (TSAs) for new studiesOversee and coordinate daily clinical research operations, including regulatory submissions, patient screening and enrollment, data entry, and comprehensive study managementSupport and guide patients through study participation activities, ensuring protocol compliance, accessibility, and participant engagementPlan, organize, and lead study team meetings, driving alignment, accountability, and progress toward key milestonesMonitor study performance metrics and collaborate closely with Principal Investigator (PIs) to ensure timeliness, deliverables, and regulatory obligations are metEnforce adherence to federal, VA, and ethical research regulations, maintaining continuous compliance throughout the study lifecycleMaintain complete, accurate, and audit-ready research records in accordance with VA, FDA, and Good Clinical Practices (GCP) standardsSynthesize and communicate research progress, risks, and findings to sponsors, investigators, and senior stakeholdersMinimum QualificationsBachelor's degree required; Master's degree or Nursing degree preferredDemonstrate experience in VA clinical research coordination, with oncology research experience strongly preferredMinimum of ten (10) years of experience implementing and overseeing clinical research regulatory requirementsProven ability to manage multiple complex priorities with a high level of attention to detail and accuracyExceptional organizational, interpersonal, and written and oral communication skillsExperience working with electronic medical records (EMR/EHR) systems in clinical or research settingsAbility to operate independently in a lead role while collaborating effectively within multidisciplinary teamsStrong analytical and problem-solving skills, with the ability to resolve regulatory and operational challengesHands-on experience with REDCap for clinical research data capture and managementAbility to work in the U.S. indefinitely without sponsorshipAbility to obtain a public trust